Pfizer

The Chief Medical Affairs Office's Evidence Generation (EvGen) Platform is responsible for establishing global scientific leadership and stature through the generation of integrated, end-to-end observational real-world evidence serving all therapeutic areas from proof of concept (POC) trials through LOE for priority pipeline candidates, pipeline supplementation through business development, and marketed inline products.. The Platform fully centralizes RWE, epidemiology, outcomes research, RW-relevant health informatics, and biostatistics talent from global, international developed market (IDM) and emerging markets (EM) into one team to drive efficiency through internalized work.. support differentiated product labels for Product Development programs including finding alternatives and accelerated licensure pathways for new indications through the use of Real World Data (RWD), Real World Insights (RWI) and Real World Evidence (RWE). Outside of the Platform, the Head will work with leaders from Biostatistics & Data Management, Global Regulatory Affairs, Clinical Pharmacology / Pharmacometrics, HEOR, Legal/Compliance, and others to achieve research and business objectives.. Collaborates with RWE Platforms and Partnerships colleagues, EvGen Strategic Planning Innovation, Biostatistics, Statistical Programming and Digital to identify and fill RWD gaps using fit-for-purpose sources worldwide, incorporate advanced analytical and machine learning approaches, and scale innovations across category teams

epidemiology

Pfizer VP, Head of RWE Science & Epidemiology in Lake Forest , Illinois ROLE SUMMARY
The Platform: The Chief Medical Affairs Office's Evidence Generation (EvGen) Platform is responsible for establishing global scientific leadership and stature through the generation of integrated, end-to-end observational real-world evidence serving all therapeutic areas from proof of concept (POC) trials through LOE for priority pipeline candidates, pipeline supplementation through business development, and marketed inline products. The Platform fully centralizes RWE, epidemiology, outcomes research, RW-relevant health informatics, and biostatistics talent from global, international developed market (IDM) and emerging markets (EM) into one team to drive efficiency through internalized work.
The Platform functions to:
enhance Pfizer's ability to determine unmet medical needs
support differentiated product labels for Product Development programs including finding alternatives and accelerated licensure pathways for new indications through the use of Real World Data (RWD), Real World Insights (RWI) and Real World Evidence (RWE)
inform clinical practice on appropriate prescription and use of Pfizer's products
in collaboration with Access & Value, strengthen the value evidence package for payers and access/policy decision-makers
support measurement of short- and long-term impact of Pfizer's products to both patients and populations
RWE, other patient-centric evidence, and RWI will be generated by the Platform for all global, prioritized IDM and prioritized EM needs through a combinatorial approach of cutting edge retrospective data analyses, site-based evaluations (e.g., Phase IV observational effectiveness studies, burden of illness, transmission, pathogenesis, risk factors for illness, determinants of product effectiveness and other studies), application of novel methods and technologies, and supplementation of interventional trials where appropriate with RWE through hybrid trial designs and tokenization.
The opportunity: The RWE Science & Epidemiology capability is the primary execution arm of the EvGen Platform for retrospective RWE generation using retrospective RWD sources or technology-based direct-from-patient approaches for observational, hybrid interventional / RWE trials and other approaches. For prospective observational research, a second execution-dedicated team of Clinical Scientists & Clinical Operations colleagues provides dedicated support.
This role leads a team of 60 Sr Director through Manager-level RWE Scientist & Epidemiologists in category-dedicated teams. The Head's leadership team will serve as single points of contact for all RWE Science & Epidemiology execution needs as articulated in Integrated Evidence Plans, project plans and other priorities identified by RWE Strategy Leads for the category and for the category-aligned Clinical Science Leads.
The Head will be responsible for understanding and translating RWE Strategies developed by RWE Strategy Leads with cross-functional teams into actionable project plans and ensuring high quality and timely delivery of compliant RWE and insights. To do so, the head develops KPIs and success metrics with each of their category-aligned teams and other Platform colleagues. They then direct their teams to work in highly-matrixed cross-functional teams to design study concepts, draft protocols that are robustly designed, leverage knowledge of RWD and data standards, incorporate knowledge of standard of care and endpoints for given categories, ensure high quality SAPs, and deliver RWE to teams for interpretation and dissemination. The lead will also direct their teams to rapidly communicate successes, publications, external speaking engagements, and lessons learned to the EvGen Impact Translation lead.
This leader will also work across other Platform capabilities' senior leaders and in collaborations with Platform peers including VPs and Heads of Evidence Strategic Planning & Business Operations, RWE Clinical Affairs & Clinical Operations, Study Quality & Compliance, and RWE Platforms & Partnerships.
Outside of the Platform, the Head will work with leaders from Biostatistics & Data Management, Global Regulatory Affairs, Clinical Pharmacology / Pharmacometrics, HEOR, Legal/Compliance, and others to achieve research and business objectives. They will also serve as an external face for study execution to Pfizer, providing expert epidemiological, statistical, methodological and execution excellence knowledge to its leaders. They will also serve as a trusted expert with study / analytical KOLs, key regulatory agencies (e.g., FDA in the US, EMA in Europe, MHRA in the UK, PDMA in Japan, CDE in China), HTAs/Payers, and other stakeholders.
They will be responsible for helping to create integrated evidence plans with cross-functional partners, determining the best methodological approaches and study designs, providing feedback on tactic and project feasibility, selecting appropriate real world databases, and ultimately for delivering upon all in-scope evidence. They will monitor their teams' performance and report metrics, challenges and opportunities back to the CMAO Evidence Generation.
ROLE RESPONSIBILITIES
Create a vision for patient-centric early integrated evidence generation for the Pfizer enterprise at a global, regional and local level and ensure that the Platform at-large is delivering on the vision and ambition across teams
Identifies, monitors and reports on study progress and KPIs for the team
Direct and lead a team of Sr Director team leaders and Sr Director through Manager-level individual contributor RWE Scientists and Epidemiologists to establish category-level RWE execution approaches, operating models and quality control procedures in accordance with relevant Pfizer SOPs and industry best practices
Oversees and, through their category-aligned team leads, manages queue of scientific design and execution work for prioritized global, regional and local studies
Establishes operating and resourcing model for RWE Scientists & Epidemiologists in partnerships with EvGen Business Operations
Directs leadership team in technical and operational excellence and serves as a senior leader to their organization for statistical, design and analytical challenges
Collaborates with RWE Platforms and Partnerships colleagues, EvGen Strategic Planning Innovation, Biostatistics, Statistical Programming and Digital to identify and fill RWD gaps using fit-for-purpose sources worldwide, incorporate advanced analytical and machine learning approaches, and scale innovations across category teams
Leads team to build upon a culture of continuous learning & objective measurements activities for end-to-end evidence generation.
Directs teams to consult with EvGen Clinical Scientists on appropriate methods for site-based RWE generation
Directs leadership team to proactively ensure study quality assurance with EvGen Quality & Compliance, including appropriate conduct in accordance with Pfizer SOPs and industry best practices, mock audits or inspections, and ongoing evidence quality trainings
Drives standards for cross-functional team-endorsed cohort definitions and business rules, versioning those rules to meet various use cases & ensuring that teams systematically incorporate these rules into their work for consistency across the lifecycle
Holds their team accountable for management & development of a diverse talent pipeline
Serve as a leading internal RWE scientific expert and external face of Pfizer at global technical conferences, events and initiatives. Advocate and champion for the science and clinical value of Pfizer's pipeline & products within the target asset classes and for transformative policy changes to increase global regulatory agency, patient and provider confidence in and acceptance of RWE.
BASIC QUALIFICATIONS
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Advanced degree, including MD, PhD or equivalent qualifications.
The incumbent must have at least Bachelors + 20 years' experience hands-on expertise and in leading teams with multiple of the following disciplines and approaches: site-based epidemiology, pharmacoepidemiology, database analysis, statistics, study design, basic science, clinical characteristics, pharmaceutical safety, pathophysiology, retrospective RWD sources, and RWE-adjacent enabling technologies and approaches; Masters/MPH and at least 18 years' experience; PHD/PharmD and at least 15+ years' experience; MD and at least 9+ years' experience. Candidates who have only outsourced study design and execution need not apply.
Demonstrated expertise in at least two categories
Familiarity with product development; this does not require previous pharmaceutical experience, as work on new products (e.g., effectiveness studies) could be done through an academic appointment.
Experience having led and grown (staff and budget) at least one organizational structure with substantial supervisory (at least 10 people with responsibility for hiring) & fiscal / budgetary responsibility
A high degree of energy, enthusiasm and motivation for scientific discoveries and developing a team
Significant cross-functional leadership/management experience including colleagues from different countries and cultures
Leadership in a related scientific field, e.g., in professional societies, government, international bodies, etc.
Global recognition as a scientific leader with e.g., 50 scientific publications in peer-reviewed journals and conference proceedings in areas relevant for the target assets
Demonstration of a wide network of peers in a relevant disciplines (e.g., co-authors and participation on professional societies, technical working groups, committees, etc.)
Demonstrated ability to create and articulate global strategies, supervise & develop highly-skilled and seasoned professionals, and to lead across diverse cultures and geographies through influence even in the absence of authority
Able to act independently as well as cross-functionally to achieve program goals
Excellence in speaking/communicating publicly as evidenced by presentations at congresses, participation on committees/working groups, etc.
Demonstrated strong work ethic, and proven track record of delivering high quality within timelines.
Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to set budgets.
Ability to discuss scientific aspects of drug development, also comfortable in discussing commercial and regulatory issues.
Able to lead teams through ambiguity and have them excited to follow a vision
PREFERRED QUALIFICATIONS
Successfully executed a major late phase development or post-approval pharmaceutical product program.
A blend of non-pharmaceutical (academia, government, NGO) and pharmaceutical experience in relevant areas for target assets; pharmaceutical experience could be through partnerships or engagement in sponsored trials/studies rather than through employment
Experience working with key regulatory agencies (FDA, EMA, MHRA, etc.) regarding pharmaceutical indication and/or labeling issues.
Experiences overseeing or implementing studies in multiple settings globally (e.g., both developed and developing countries)
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Travel of 20-50%, depending on budgets, organizational needs, and any other relevant restrictions
Other Job Details:
Last Date to Apply for Job: March 6th, 2024
Additional Location Information: Global - Any Pfizer site
Eligible for Relocation Package: No
#LI-PFE
The annual base salary for this position ranges from $262,100.00 to $436,800.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 30.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. #J-18808-Ljbffr

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